Our future appears to be in good hands after all. Following on our earlier editorial, here’s a broader measure of the motivations and modus operandi of the youth inhabiting our drug development industry as we head into the 2020s … a decade they can conquer utilizing our outsourcing industry.
The CDMO industry has benefitted from big pharma’s divestment of in-house development and manufacturing capabilities in this current economic cycle. The sector has grown at a consistent 7 percent compound annual growth rate (CAGR) for the better part of a decade, outpacing that of the greater pharmaceutical industry itself. The rise of competition from new CDMO players and consolidation within the pharmaceutical sponsor space, however, has led to a crowded market and, in many cases, a commoditized service base.
Industries can (and should) learn from one another. As the life sciences market continues to become more competitive and social pressure to reduce healthcare costs increases, consumer packaged goods (CPG) approaches and strategies to cut packaging costs can be applied to life sciences to achieve these objectives.
Whether Inter Partes Review (IPR) is the right choice for biosimilar developers will depend on the particular circumstances surrounding each drug candidate. But given the benefits of IPR proceedings, they must at least be considered as a potential tool for challenging patents.
Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.
Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, so it is critical you find a partner that can help you overcome the inevitable challenges of drug development.
When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.
This whitepaper is an overview of a prospective cohort study of approximately 3,000 Golden Retrievers under the age of 2 years at enrollment and how the extensive data and biological sample repositories will be used for future analyses of major diseases, disorders or conditions in Golden Retrievers.
How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.
This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.
This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.
When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.
A selection of fluid management components from GE Healthcare’s ReadyToProcess platform of disposable and single-use equipment was used to arrange buffer and sample management solutions for four typical large-scale chromatography setups.
To drive dependable critical process control requirements, Biogen explored novel strategies to increase process and raw material control and optimize communication of data throughout the supply chain.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Metabolic disease disrupts normal metabolism, resulting in altered systemic physiology. A challenge posed by metabolic diseases is that they are often present for years prior to becoming clinically apparent.
When building a new facility based on single-use technologies, or incorporating single-use into an existing facility, how do companies ensure they fully realize the benefits?
As everyone who deals with the EU and the UK in drug safety knows, the EMA issued a new set of Good PV Guidelines to replace (largely) Volume 9A. By Bart Cobert
This is the fifth article in a six-part series summarizing each of the FDA's gene therapy draft guidance documents. It will discuss the draft guidance Human Gene Therapy for Retinal Disorders.
This article presents a totality of evidence approach to show superior sterility performance of a well-designed closed system compared to conventional aseptic processing, and to design the control strategy.
